Understanding Executive Orders and Trial Compliance

In a recent video interview with Applied Clinical Trials, Kate Gallin, Heffernan, life sciences attorney, Epstein Becker Green, discussed the challenges clinical research teams face with compliance due to evolving executive orders and federal funding policies. She highlighted the confusion and increased scrutiny on research projects, particularly those involving diverse populations. Practical risks include potential legal scrutiny and funding agency actions. Heffernan also emphasized the importance of accurate reporting and careful documentation to avoid false claims. Future-proofing compliance involves thorough portfolio assessments, diversifying funding sources, and strengthening partnerships between academia and industry to support early-stage research and innovation.

ACT: As executive orders increasingly shape the regulatory landscape, how should clinical research teams think about compliance when federal funding is involved?

Heffernan: It's a great question. It's been one of the biggest challenges of 2025. It's not like we haven't had executive orders, obviously, in other administrations, but the ones we've seen this year, while they have obviously reached a broad array of topics, many of them do touch on research, given the nexus with federal funding. As I'm sure you know, the challenge with digesting and understanding the impact of things like executive orders is that they really are limited in enforceability at the time that they're proclaimed. They really are more of a statement of the administration's policy, direction, and the way in which the administration would like to see agencies and congress, and other parts of the government carry out that policy. Many of them are limited as far as their immediate enforceability. However, we've seen a number of them obviously direct the agencies that fund a lot of our clients’ research to take certain steps to ensure that that federal funding is not being used in furtherance of aims that are not aligned with the administration's policy. I think that has put many of our clients, clinical trial researchers, and the organizations that they work for in a little bit of limbo, because they know that there is a stated aim or policy that the administration is trying to accomplish. There's a lot of, I think, confusion in the research and scientific community about what is law at this time. Many people, I think, just in the lay public, misunderstand executive orders as being a legally binding proclamation, and so that alone has engendered a lot of confusion in the regulated community, just about, where is the law in this moment, and what do we have to do to be compliant right now? Whether or not an executive order is yet enforced, no matter what it is, portending, I think, the direction that we've obviously seen, the administration continued to move, as far as further actions taken by the funding agencies themselves and other offices within the government, so no matter what they are a window into what's coming, and a way for research teams and research organizations to give thought to what will we have to do to pivot or to bring our programs into compliance if we end up with laws that actually enforce these types of orders.